[18F]FMISO PET/CT After Transcatheter Arterial Embolization in Imaging Tumors in Patients With Liver Cancer
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|ClinicalTrials.gov Identifier: NCT02695628|
Recruitment Status : Recruiting
First Posted : March 1, 2016
Last Update Posted : March 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adult Liver Carcinoma Liver Cirrhosis||Drug: 18F-Fluoromisonidazole Procedure: Arterial Embolization Diagnostic Test: Computed Tomography Diagnostic Test: Positron Emission Tomography||Phase 2|
I. Determine the variability of 18F FMISO uptake in hepatocellular carcinoma (HCC) tumors compared to normal liver after transcatheter arterial embolization by determining the difference in the mean of the maximum standardized uptake value (SUVmax) and tumor-to-liver ratio (TLR) of a region of normal liver and of up to 5 index tumors.
I. Determine if areas of tumor recurrence as determined by CT or magnetic resonance imaging (MRI) within a 6 month period after transcatheter arterial embolization show evidence of increased 18F FMISO labeling on the initial post treatment 18F FMISO PET/CT.
II. Determine the variability in SUVmax and TLR of untreated (non embolized) HCC lesions compared to normal liver by determining the difference in the mean of the SUVmax and TLR of normal liver and tumor.
III. Determine any toxicities related to [18F]FMISO use for PET/CT.
Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole intravenously (IV) and undergo PET/CT scans within 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.
After completion of treatment, patients are followed up at 2 and 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of Treatment-Induced Tissue Hypoxia After Transcatheter Arterial Embolization of Hepatocellular Carcinoma: A Feasibility Study With [18F]FMISO PET/CT|
|Actual Study Start Date :||September 13, 2016|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||October 2018|
Experimental: Diagnostic (18F-fluoromisonidazole, PET/CT, embolization)
Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.
Undergo [18F] FMISO PET/CT
Other Names:Procedure: Arterial Embolization
Undergo transcatheter arterial embolization
Other Names:Diagnostic Test: Computed Tomography
Undergo [18F] FMISO PET/CT
Other Names:Diagnostic Test: Positron Emission Tomography
Undergo [18F] FMISO PET/CT
- Change in SUVmax and TLR of tumors [ Time Frame: Within 4 hours prior to embolization treatment up to 20 hours following embolization ]TLR of SUVmax will be calculated for all imaged tumors and analyzed on the logarithmic scale. A variance components model (linear mixed effects with a random intercept for subject effect) will be fitted to the TLR; in such a model the antilog of the overall intercept can be interpreted as an overall TLR averaged across tumors and subjects. Up to 5 tumors per subject will be obtained. The between subject and within subject variance components will be used to plan further studies. The overall TLR will be reported with a P value obtained from the variance components model. A P value less than 0.0
- Comparison of SUVmax and TLR of tumors with recurrence to tumors without recurrence [ Time Frame: Up to 6 months ]Logistic regression analysis will be performed on the independent variables, SUVmax and TLR, and the dependent variable, recurrence of tumor. An odds ratio and 95% confidence interval will be obtained.
- Incidence of unanticipated toxicities related to 18F-fluoromisonidazole use over a 10 half-life period beginning from injection according to the Common Terminology Criteria for Adverse Events version 4 [ Time Frame: 18 hours following injection ]Toxicity rates will be calculated and reported as a proportion of number of complications/number of total treatments with a corresponding 95% confidence interval.
- Measurement of SUVmax and TLR of untreated HCC tumor compared to normal liver, defined as any tumor that has not undergone any locoregional or systemic treatment within 3 months [ Time Frame: Up to 3 months ]TLR of SUVmax will be calculated for all imaged tumors and analyzed on the logarithmic scale. A variance component model will be fitted to the TLR. The overall TLR will be reported with a P value obtained from the variance components model. A P value less than 0.05 will be considered significant.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02695628
|United States, California|
|VA Palo Alto Healthcare System||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Rajesh Shah 650-723-0728|
|Principal Investigator: Rajesh Shah|
|Principal Investigator:||Rajesh Shah||Stanford Cancer Institute|